A Phase III, Open Label, Randomized Study of AZD9291 versus Platinum-Based Doublet Chemotherapy for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer whose Disease has Progressed with Previous Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy and whose Tumours harbour a T790M mutation within the Epidermal Growth Factor Receptor Gene (AURA3)

Phase 3

Recruiting

Conditions: lung cancer
Non small cell lung cancer
10038666

Registration Number: NL-OMON42148

Lead Sponsor: Astra Zeneca

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

- Subjects with histologically- or cytologically-documented NSCLC.
- Locally advanced or metastatic NSCLC.
- Radiological documentation of disease progression following 1st line EGFR TKI Treatment without any further treatment.
- Eligible to receive treatment with the selected doublet-chemotherapy.
- Confirmation of EGFR mutation.
- Central confirmation of T790M+ mutation status.
- World Health Organisation (WHO) performance status 0-1.
- At least one lesion, not previously irradiated.

Exclusion Criteria

- Treatment with more than one prior line of treatment for advanced NSCLC.
- Treatment with an approved EGFR-TKI (eg, erlotinib, gefitinib, afatinib) within 8 days or approximately 5 x half-life of the first dose of study treatment.
- Any cytotoxic chemotherapy, investigational agents or other anticancer drugs from a previous treatment regimen or clinical study within 14 days of the first dose of study treatment.
- Previous treatment with an unapproved EGFR-TKI.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Progression Free Survival (PFS)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Objective Response Rate (ORR)<br /><br>- Duration of response (DOR)<br /><br>- Disease Control Rate (DCR)<br /><br>- Tumor shrinkage<br /><br>- Overall survival (OS)<br /><br>- To assess the effect of AZD9291 compared to platinum-based doublet<br /><br>chemotherapy on disease related symptoms and quality of life<br /><br>- To characterise the pharmacokinetics of AZD9291 and metabolites in subjects<br /><br>receiving AZD9291<br /><br>- Safety<br /><br>- Tolerability</p><br>